Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Smoking Cessation

Treatments: Drug: surinabant (SR147778); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432575

EUDRACT: 2006-005334-2L

DRI6938

Details and patient eligibility

About

Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine.

The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.

Enrollment: 810 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.

Exclusion criteria

• Patients with a limited level of motivation.
• Other participant in a household enrolled in the study.
• Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product more than 3 days within the 3 months preceding the screening visit.
• Patients dependent to alcohol or illicit drugs.
• Patients with a diagnosis of Psychotic Disorder or currently presenting with a Depressive Episode.
• Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past 6 months prior to screening.
• Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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810 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Active Comparator group

Description:

surinabant 2,5 mg/day

Treatment:

Drug: surinabant (SR147778)

3

Active Comparator group

Description:

surinabant 5 mg/day

Treatment:

Drug: surinabant (SR147778)

4

Active Comparator group

Description:

surinabant 10 mg/day

Treatment:

Drug: surinabant (SR147778)